Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

NCT ID: NCT02888561

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-06-30

Brief Summary

Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Dobutamine

Dobutamine will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.

Intervention Type: DRUG

Nitrite

Nitrite will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Left Ventricular Ejection Fraction <40%

2. Patients aged >18 years

3. Able to provide written consent

Exclusion Criteria

1. Known acquired or congenital structural heart disease such as severe valve disease, ventricular/atrial septal defects

2. Haemodynamic Instability

3. Severe disease in major proximal coronary arteries or planned percutaneous coronary intervention during the index procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

Facility Contacts

Natalia Briceno, MBBS BSc

Role: primary

natalia.briceno@kcl.ac.uk

Divaka Perera, MD

Role: backup

divaka.perera@kcl.ac.uk

Other Identifiers

199826

Identifier Type: -

Identifier Source: org_study_id